initiatives. In this position, you will lead the operational execution and oversight of Investigator Initiated Studies (IIS... who thrives in a fast-moving, global environmen Key responsibilities: Serve as the primary point of contact for IIS...
as Quantitative Risk Vice President. This role will report to senior model validation lead, within Model Risk Management Department... you are up for. What you will be responsible for As Quantitative Risk, Vice President you will: Lead a team under the...
for finalization. Serve as a contributing author to pathology sections of regulatory documents such as INDs, NDA/BLAs, IBs..., and respond to Health Authority questions. Contribute to and/or lead the communication of safety study results and conclusions...
in Oncology. You will work in close collaboration with the Global Development Lead (GDL)and members of the development team... RESPONSIBILITIES Partner closely with the Global Development Lead (GDL) in the execution of the clinical development strategy...
Summary The Principal Cloud Infrastructure Engineer will lead the design, implementation, and optimization of enterprise... service delivery across the enterprise. Key Duties & Responsibilities Azure Infrastructure Architecture & Strategy: Lead...
Development Lead to drive growth across Drug Delivery and Medical Device clients on a global basis, with many clients... forefront of drug delivery device development for more than 30 years, supporting a global client base of pharmaceutical...
will lead a strategic initiative to design, build, and scale a platform of affiliated advisors, Longer. Healthier.... Lead Generation & Routing Operationalize lead framework across multiple channels (site, partner leads, events, paid media...
Senior Auditor up to $150k – Leasing Firm Join a leading global company as a Senior IT Auditor and play a key role... days, ensuring a great work-life balance. Utilize your expertise to lead risk-focused IT audits, evaluate business...
and data integrity requirements. This role ensures IT systems and processes meet global regulatory requirements and internal...Position Overview The Director, IT Quality Compliance provides strategic and regulatory compliance subject matter...
The Brattle Group, a privately held, global economics consulting firm, is looking for a Senior Manager, Billing... policies, client requirements, and applicable local, state, and international regulations Lead, mentor, and develop the...
on relationship management and efficiency Lead the proactive identification, assessment, and management of clinical study challenges... clinical sections of regulatory documents including Investigators' Brochures, safety updates, and responses to Health Authority...
function, ensuring scientific excellence and regulatory compliance Lead late-stage analytical development, method transfer..., stability, and characterization assays. Proven experience with global regulatory submission and inspections Experience...
, and implementing amendments to clinical protocols in close collaboration with the clinical lead. Create study-level documents..., including preparing clinical sections of key regulatory documents such as Investigator Brochures, briefing books, safety updates...
, and reports. Assist with regulatory agency inspections Identify and facilitate continuous improvement efforts Support the lead... quality issues to ensure compliant solutions Lead root-cause analysis and product impact assessment for investigations...
Company Overview Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives... Manager, Data Management acts as the Lead Data Manager for multiple clinical studies and/or a clinical development program...
Lead root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT... Quality on cross functional working teams, applying strong communication and collaboration skills. Lead continuous...
Participate in inspection readiness activities and lead Quality development discussions as necessary during regulatory site... inspections. Support review of regulatory submissions, as applicable Lead continuous improvements of department processes...
Contributions: You will lead and assist with field activities, regulatory compliance and reporting, contamination assessments..., MA. This role includes being a lead technical expert in the environmental remediation sector supporting various core markets...
Group (“ISG”), a global multi-asset class solutions team. This position reports to the Managing Director, Head of OCIO... management analytic services is required. In addition, the candidate will also lead the liability assessment, spending analysis...
) strongly preferred Demonstrated expertise in clinical trial operations, GCP, ICH guidelines, and global regulatory... requirements Proven ability to lead complex, multi-site and/or global clinical studies across multiple vendors Strong strategic...